NCT04287920已完成2 期
A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
Is acamprosate safe to use in individuals with liver disease.
详细描述
Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alcohol-related liver disease and AUD, MELD-NA less than 20
Experimental
The first 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score less than 20.
干预措施: Acomprosate (Drug)
Alcohol-related liver disease and AUD, MELD-NA more than 20
Experimental
The second 5 patients enrolled = AUD (alcohol use disorder) w/MELD-Na (model for end stage liver disease sodium) score more than 20.
干预措施: Acomprosate (Drug)
结局指标
主要结局
Adverse Event
时间窗: 24 weeks
Number of adverse events reported
次要结局
- Change in Alcohol Craving(Baseline, week 24)
研究者
Douglas (Doug) A. Simonetto
Principal Investigator
Mayo Clinic
研究点 (1)
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